Texas Prior Authorization Program Clinical Edit Criteria
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1 Texas Prior Authorization Program Clinical Edit Criteria Drug/Drug Class Clinical Edit Information Included in this Document Provigil (Modafinil) Drugs requiring prior authorization: the list of drugs requiring prior authorization for this clinical edit Prior authorization criteria logic: a description of how the prior authorization request will be evaluated against the clinical edit criteria rules Logic diagram: a visual depiction of the clinical edit criteria logic Supporting tables: a collection of information associated with the steps within the criteria (diagnosis codes, procedure codes, and therapy codes); provided when applicable References: clinical publications and sources relevant to this clinical edit te: Click the hyperlink to navigate directly to that section. Nuvigil (Armodafinil) Drugs requiring prior authorization: the list of drugs requiring prior authorization for this clinical edit Prior authorization criteria logic: a description of how the prior authorization request will be evaluated against the clinical edit criteria rules Logic diagram: a visual depiction of the clinical edit criteria logic Supporting tables: a collection of information associated with the steps within the criteria (diagnosis codes, procedure codes, and therapy codes); provided when applicable References: clinical publications and sources relevant to this clinical edit te: Click the hyperlink to navigate directly to that section. October 5, 2017 Copyright 2017 Health Information Designs, LLC 1
2 Revision tes Annual review by staff Added dose check to modafinil logic and diagram, pages 4-5 Added armodafinil to clinical edit Added criteria logic and diagram for armodafinil, pages Updated references, page 17 October 5, 2017 Copyright 2017 Health Information Designs, LLC 2
3 Provigil Drugs Requiring Prior Authorization Drugs Requiring Prior Authorization Label Name GCN MODAFINIL 100 MG TABLET MODAFINIL 200 MG TABLET PROVIGIL 100 MG TABLET PROVIGIL 200 MG TABLET October 5, 2017 Copyright 2017 Health Information Designs, LLC 3
4 Provigil Clinical Edit Criteria Logic 1. Is the client greater than or equal to () 16 years of age? [ ] (Go to #2) [ ] (Deny) 2. Does the client have a diagnosis of narcolepsy or shift work disorder in the last 730 days? [ ] (Go to #5) [ ] (Go to #3) 3. Does the client have a diagnosis of obstructive sleep apnea in the last 730 days? [ ] (Go to #4) [ ] (Deny) 4. Does the client have a procedure code for CPAP or BiPAP in the last 730 days? [ ] (Go to #5) [ ] (Deny) 5. Does the client have a diagnosis of severe hepatic impairment in the past 365 days? [ ] (Go to #6) [ ] (Go to #7) 6. Is the dose less than or equal to ( ) 100mg per day? [ ] (Approve 365 days) [ ] (Deny) 7. Is the dose less than or equal to ( ) 200mg per day? [ ] (Approve 365 days) [ ] (Deny) October 5, 2017 Copyright 2017 Health Information Designs, LLC 4
5 Provigil Clinical Edit Criteria Logic Diagram Step 1 Is the client 16 years of age? Deny Request Step 2 Step 5 Step 6 Does the client have a diagnosis of narcolepsy or shift work disorder in the last 730 days? Does the client have a diagnosis of severe hepatic impairment in the last 365 days? Is the dose 100mg per day? Approve Request (365 days) Step 3 Step 4 Step 7 Does the client have a diagnosis of obstructive sleep apnea in the last 730 days? Does the client have a procedure code for CPAP or BiPAP in the last 730 days? Is the dose 200mg per day? Deny Request Deny Request Deny Request Approve Request (365 days) October 5, 2017 Copyright 2017 Health Information Designs, LLC 5
6 Provigil Clinical Edit Criteria Supporting Tables ICD-9 Code Step 2 (diagnosis of narcolepsy or shift work disorder) Description Required diagnosis: 1 Look back timeframe: 730 days CIRCADIAN RHYTHM SLEEP DISORDER, OF NON ORGANIC CIRCADIAN RHYTHM SLEEP DISORDER, SHIFT WORK TYPE NARCOLEPSY,WITHOUT CATAPLEXY NARCOLEPSY,WITH CATAPLEXY NARCOLEPSY IN CONDITIONS CLASSIFIED ELSEWHERE, WITHOUT CATAPLEXY NARCOLEPSY IN CONDITIONS CLASSIFIED ELSEWHERE, WITH CATAPLEXY ICD-10 Code Description F518 G4726 G47411 G47419 G47421 G47429 OTHER SLEEP DISORDERS NOT DUE TO A SUBSTANCE OR KNOWN PHYSIOLOGICAL CONDITION CIRCADIAN RHYTHM SLEEP DISORDER, SHIFT WORK TYPE NARCOLEPSY WITH CATAPLEXY NARCOLEPSY WITHOUT CATAPLEXY NARCOLEPSY IN CONDITIONS CLASSIFIED ELSEWHERE WITH CATAPLEXY NARCOLEPSY IN CONDITIONS CLASSIFIED ELSEWHERE WITHOUT CATAPLEXY Step 3 (diagnosis of obstructive sleep apnea) Required diagnosis: 1 Look back timeframe: 730 days ICD-9 Code Description OBSTRUCTIVE SLEEP APNEA (ADULT) INSOMNIA WITH SLEEP APNEA UNSPECIFIED HYPERSOMNIA WITH SLEEP APNEA UNSPECIFIED UNSPECIFIED SLEEP APNEA ICD-10 Code Description G4730 SLEEP APNEA, UNSPECIFIED G4733 OBSTRUCTIVE SLEEP APNEA (ADULT) (PEDIATRIC) October 5, 2017 Copyright 2017 Health Information Designs, LLC 6
7 Step 4 (procedure code for CPAP or BiPAP) Required procedure: 1 Look back timeframe: 730 days CPT Code Description 9390 CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) CPAP INITIATION AND MANAGEMENT SLEEP STAGING WITH INITIATION OF CPAP E0601 CPAP DEVICE E0470 CPAP WITH BI-LEVEL FAILURE E0471 CPAP WITH BI-LEVEL FAILURE E0472 CPAP WITH BI-LEVEL FAILURE Step 5 (diagnosis of clinically-significant hepatic impairment) Required diagnosis: 1 Look back timeframe: 365 days ICD-9 Description 0700 HEPATITIS A WITH COMA 0701 HEPATITIS A W/O COMA HPT B ACTE COMA WO DLTA HPT B ACTE COMA W DLTA HPT B CHRN COMA WO DLTA HPT B CHRN COMA W DLTA HPT B ACTE WO CM WO DLTA HPT B ACTE WO CM W DLTA HPT B CHRN WO CM WO DLTA HPT B CHRN WO CM W DLTA ACUTE HEPATITIS C WITH HEPATIC COMA HPT DLT WO B W HPT COMA HPT E W HEPAT COMA CHRNC HPT C W HEPAT COMA OTH VRL HEPAT W HPT COMA ACUTE HEPATITIS C WITHOUT MENTION OF HEPATIC COMA HPT DLT WO B WO HPT COMA HPT E WO HEPAT COMA CHRNC HPT C WO HPAT COMA OTH VRL HPAT WO HPT COMA 0706 VIRAL HEPAT NOS W COMA UNSPECIFIED VIRAL HEPATITIS C WITHOUT HEPATIC COMA October 5, 2017 Copyright 2017 Health Information Designs, LLC 7
8 Step 5 (diagnosis of clinically-significant hepatic impairment) Required diagnosis: 1 Look back timeframe: 365 days UNSPECIFIED VIRAL HEPATITIS C WITH HEPATIC COMA 0709 VIRAL HEPAT NOS W/O COMA 5710 ALCOHOLIC FATTY LIVER 5711 AC ALCOHOLIC HEPATITIS 5712 ALCOHOL CIRRHOSIS LIVER 5713 ALCOHOL LIVER DAMAGE NOS CHRONIC HEPATITIS NOS CHR PERSISTENT HEPATITIS AUTOIMMUNE HEPATITIS CHRONIC HEPATITIS NEC 5715 CIRRHOSIS OF LIVER NOS 5716 BILIARY CIRRHOSIS 5718 CHRONIC LIVER DIS NEC 5719 CHRONIC LIVER DIS NOS 5720 ABSCESS OF LIVER 5721 PORTAL PYEMIA 5722 HEPATIC ENCEPHALOPATHY 5723 PORTAL HYPERTENSION 5724 HEPATORENAL SYNDROME 5728 OTH SEQUELA, CHR LIV DIS 5730 CHR PASSIV CONGEST LIVER 5731 HEPATITIS IN VIRAL DIS 5732 HEPATITIS IN OTH INF DIS 5733 HEPATITIS NOS 5734 HEPATIC INFARCTION 5738 LIVER DISORDERS NEC 5739 LIVER DISORDER NOS ICD-10 Code B150 B159 B160 B161 B162 B169 B170 B1710 Description HEPATITIS A WITH HEPATIC COMA HEPATITIS A WITHOUT HEPATIC COMA ACUTE HEPATITIS B WITH DELTA-AGENT WITH HEPATIC COMA ACUTE HEPATITIS B WITH DELTA-AGENT WITHOUT HEPATIC COMA ACUTE HEPATITIS B WITHOUT DELTA-AGENT WITH HEPATIC COMA ACUTE HEPATITIS B WITHOUT DELTA-AGENT AND WITHOUT HEPATIC COMA ACUTE DELTA-(SUPER) INFECTION OF HEPATITIS B CARRIER ACUTE HEPATITIS C WITHOUT HEPATIC COMA October 5, 2017 Copyright 2017 Health Information Designs, LLC 8
9 B1711 B172 B178 B179 B180 B181 B182 B188 B189 B190 B1910 B1911 B1920 B1921 B199 B251 K700 K7010 K7011 K702 K7030 K7031 K7040 K7041 K709 K710 K7110 K7111 K712 K713 K714 K7150 K7151 K716 K717 Step 5 (diagnosis of clinically-significant hepatic impairment) Required diagnosis: 1 Look back timeframe: 365 days ACUTE HEPATITIS C WITH HEPATIC COMA ACUTE HEPATITIS E OTHER SPECIFIED ACUTE VIRAL HEPATITIS ACUTE VIRAL HEPATITIS, UNSPECIFIED CHRONIC VIRAL HEPATITIS B WITH DELTA-AGENT CHRONIC VIRAL HEPATITIS B WITHOUT DELTA-AGENT CHRONIC VIRAL HEPATITIS C OTHER CHRONIC VIRAL HEPATITIS CHRONIC VIRAL HEPATITIS, UNSPECIFIED UNSPECIFIED VIRAL HEPATITIS WITH HEPATIC COMA UNSPECIFIED VIRAL HEPATITIS B WITHOUT HEPATIC COMA UNSPECIFIED VIRAL HEPATITIS B WITH HEPATIC COMA UNSPECIFIED VIRAL HEPATITIS C WITHOUT HEPATIC COMA UNSPECIFIED VIRAL HEPATITIS C WITH HEPATIC COMA UNSPECIFIED VIRAL HEPATITIS WITHOUT HEPATIC COMA CYTOMEGALOVIRAL HEPATITIS ALCOHOLIC FATTY LIVER ALCOHOLIC HEPATITIS WITHOUT ASCITES ALCOHOLIC HEPATITIS WITH ASCITES ALCOHOLIC FIBROSIS AND SCLEROSIS OF LIVER ALCOHOLIC CIRRHOSIS OF LIVER WITHOUT ASCITES ALCOHOLIC CIRRHOSIS OF LIVER WITH ASCITES ALCOHOLIC HEPATIC FAILURE WITHOUT COMA ALCOHOLIC HEPATIC FAILURE WITH COMA ALCOHOLIC LIVER DISEASE, UNSPECIFIED TOXIC LIVER DISEASE WITH CHOLESTASIS TOXIC LIVER DISEASE WITH HEPATIC NECROSIS, WITHOUT COMA TOXIC LIVER DISEASE WITH HEPATIC NECROSIS, WITH COMA TOXIC LIVER DISEASE WITH ACUTE HEPATITIS TOXIC LIVER DISEASE WITH CHRONIC PERSISTENT HEPATITIS TOXIC LIVER DISEASE WITH CHRONIC LOBULAR HEPATITIS TOXIC LIVER DISEASE WITH CHRONIC ACTIVE HEPATITIS WITHOUT ASCITES TOXIC LIVER DISEASE WITH CHRONIC ACTIVE HEPATITIS WITH ASCITES TOXIC LIVER DISEASE WITH HEPATITIS, NOT ELSEWHERE CLASSIFIED TOXIC LIVER DISEASE WITH FIBROSIS AND CIRRHOSIS OF LIVER October 5, 2017 Copyright 2017 Health Information Designs, LLC 9
10 Step 5 (diagnosis of clinically-significant hepatic impairment) Required diagnosis: 1 Look back timeframe: 365 days K718 K719 K7201 K7210 K7211 K7290 K7291 K730 K731 K732 K738 K739 K740 K741 K742 K743 K744 K745 K7460 K7469 K750 K751 K752 K753 K7581 K7589 K759 K760 K761 K763 K764 K765 K766 K767 K7689 K769 TOXIC LIVER DISEASE WITH OTHER DISORDERS OF LIVER TOXIC LIVER DISEASE, UNSPECIFIED ACUTE AND SUBACUTE HEPATIC FAILURE WITH COMA CHRONIC HEPATIC FAILURE WITHOUT COMA CHRONIC HEPATIC FAILURE WITH COMA HEPATIC FAILURE, UNSPECIFIED WITHOUT COMA HEPATIC FAILURE, UNSPECIFIED WITH COMA CHRONIC PERSISTENT HEPATITIS, NOT ELSEWHERE CLASSIFIED CHRONIC LOBULAR HEPATITIS, NOT ELSEWHERE CLASSIFIED CHRONIC ACTIVE HEPATITIS, NOT ELSEWHERE CLASSIFIED OTHER CHRONIC HEPATITIS, NOT ELSEWHERE CLASSIFIED CHRONIC HEPATITIS, UNSPECIFIED HEPATIC FIBROSIS HEPATIC SCLEROSIS HEPATIC FIBROSIS WITH HEPATIC SCLEROSIS PRIMARY BILIARY CIRRHOSIS SECONDARY BILIARY CIRRHOSIS BILIARY CIRRHOSIS, UNSPECIFIED UNSPECIFIED CIRRHOSIS OF LIVER OTHER CIRRHOSIS OF LIVER ABSCESS OF LIVER PHLEBITIS OF PORTAL VEIN NONSPECIFIC REACTIVE HEPATITIS GRANULOMATOUS HEPATITIS, NOT ELSEWHERE CLASSIFIED NONALCOHOLIC STEATOHEPATITIS (NASH) OTHER SPECIFIED INFLAMMATORY LIVER DISEASES INFLAMMATORY LIVER DISEASE, UNSPECIFIED FATTY (CHANGE OF) LIVER, NOT ELSEWHERE CLASSIFIED CHRONIC PASSIVE CONGESTION OF LIVER INFARCTION OF LIVER PELIOSIS HEPATIS HEPATIC VENO-OCCLUSIVE DISEASE PORTAL HYPERTENSION HEPATORENAL SYNDROME OTHER SPECIFIED DISEASES OF LIVER LIVER DISEASE, UNSPECIFIED October 5, 2017 Copyright 2017 Health Information Designs, LLC 10
11 Step 5 (diagnosis of clinically-significant hepatic impairment) Required diagnosis: 1 Look back timeframe: 365 days K77 LIVER DISORDERS IN DISEASES CLASSIFIED ELSEWHERE October 5, 2017 Copyright 2017 Health Information Designs, LLC 11
12 Nuvigil Drugs Requiring Prior Authorization Drugs Requiring Prior Authorization Label Name GCN ARMODAFINIL 50MG TABLET ARMODAFINIL 150MG TABLET ARMODAFINIL 200MG TABLET ARMODAFINIL 250MG TABLET NUVIGIL 50MG TABLET NUVIGIL 150MG TABLET NUVIGIL 200MG TABLET NUVIGIL 250MG TABLET October 5, 2017 Copyright 2017 Health Information Designs, LLC 12
13 Nuvigil Clinical Edit Criteria Logic 1. Is the client greater than or equal to () 16 years of age? [ ] (Go to #2) [ ] (Deny) 2. Does the client have a diagnosis of shift work disorder in the last 730 days? [ ] (Go to #3) [ ] (Go to #4) 3. Is the dose less than or equal to ( ) 150mg per day? [ ] (Approve 365 days) [ ] (Deny) 4. Does the client have a diagnosis of narcolepsy in the last 730 days? [ ] (Go to #7) [ ] (Go to #5) 5. Does the client have a diagnosis of obstructive sleep apnea in the last 730 days? [ ] (Go to #6) [ ] (Deny) 6. Does the client have a procedure code for CPAP or BiPAP in the last 730 days? [ ] (Go to #7) [ ] (Deny) 7. Is the dose less than or equal to ( ) 250mg per day? [ ] (Approve 365 days) [ ] (Deny) October 5, 2017 Copyright 2017 Health Information Designs, LLC 13
14 Nuvigil Clinical Edit Criteria Logic Diagram Step 1 Is the client 16 years of age? Deny Request Step 2 Step 3 Does the client have a diagnosis of shift work disorder in the last 730 days? Is the dose 150mg per day? Approve Request (365 days) Step 4 Step 7 Does the client have a diagnosis of narcolepsy in the last 730 days? Is the dose 250mg per day? Approve Request (365 days) Step 5 Step 6 Does the client have a diagnosis of obstructive sleep apnea in the last 730 days? Does the client have a procedure code for CPAP or BiPAP in the last 730 days? Deny Request Deny Request Deny Request October 5, 2017 Copyright 2017 Health Information Designs, LLC 14
15 Nuvigil Clinical Edit Criteria Supporting Tables ICD-9 Code Step 2 (diagnosis of shift work disorder) Description Required diagnosis: 1 Look back timeframe: 730 days CIRCADIAN RHYTHM SLEEP DISORDER, OF NON ORGANIC CIRCADIAN RHYTHM SLEEP DISORDER, SHIFT WORK TYPE ICD-10 Code F518 G4726 Description OTHER SLEEP DISORDERS NOT DUE TO A SUBSTANCE OR KNOWN PHYSIOLOGICAL CONDITION CIRCADIAN RHYTHM SLEEP DISORDER, SHIFT WORK TYPE ICD-9 Code Description Step 4 (diagnosis of narcolepsy) Required diagnosis: 1 Look back timeframe: 730 days NARCOLEPSY,WITHOUT CATAPLEXY NARCOLEPSY,WITH CATAPLEXY NARCOLEPSY IN CONDITIONS CLASSIFIED ELSEWHERE, WITHOUT CATAPLEXY NARCOLEPSY IN CONDITIONS CLASSIFIED ELSEWHERE, WITH CATAPLEXY ICD-10 Code Description G47411 G47419 G47421 G47429 NARCOLEPSY WITH CATAPLEXY NARCOLEPSY WITHOUT CATAPLEXY NARCOLEPSY IN CONDITIONS CLASSIFIED ELSEWHERE WITH CATAPLEXY NARCOLEPSY IN CONDITIONS CLASSIFIED ELSEWHERE WITHOUT CATAPLEXY October 5, 2017 Copyright 2017 Health Information Designs, LLC 15
16 Step 5 (diagnosis of obstructive sleep apnea) Required quantity: 1 Look back timeframe: 730 days For the list of diagnosis codes that pertain to this step, see the Obstructive Sleep Apnea table in the previous Supporting Tables section. te: Click the hyperlink to navigate directly to the table. Step 6 (procedure code for CPAP or BiPAP) Required quantity: 1 Look back timeframe: 730 days For the list of procedure codes that pertain to this step, see the CPAP/BiPAP table in the previous Supporting Tables section. te: Click the hyperlink to navigate directly to the table. October 5, 2017 Copyright 2017 Health Information Designs, LLC 16
17 Clinical Edit Criteria References 1. Ballon JS, Feifel D. A systematic review of modafinil: Potential clinical uses and mechanisms of action. J Clin Psychiatry 2006;67: Psychopharmacologic Drugs Advisory Committee, United States Food and Drug Administration. March 23, Meeting minutes available at: Accessed on August 11, American Medical Association data files ICD-9-CM Diagnosis Codes. Available at 4. American Medical Association data files ICD-10-CM Diagnosis Codes. Available at 5. Clinical Pharmacology [online database]. Tampa, FL: Elsevier/Gold Standard, Inc.; Available at Accessed on June 9, Micromedex [online database]. Available at Accessed on June 9, Provigil Prescribing Information. rth Wales, PA. Teva Pharmaceuticals. January Nuvigil Prescribing Information. rth Wales, PA. Teva Pharmaceuticals. February Krahn LE, Hershner S, Loeding, LD, et al. Quality Measures for the Care of Patients with Narcolepsy. J Clin Sleep Med 2015;11(3): Epstein LJ, Kristo D, Strollo PJ, et al. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med 2009;5(3): Sack RL, Auckley D, Auger RR, et al. Circadian rhythm sleep disorders: Part I, basic principles, shift work and jet lag disorders. SLEEP 2007;30(11): October 5, 2017 Copyright 2017 Health Information Designs, LLC 17
18 Publication History The Publication History records the publication iterations and revisions to this document. tes for the most current revision are also provided in the Revision tes on the first page of this document. Publication Date tes 01/31/2011 Initial publication and posting to website 04/13/2012 Added a new section to specify the drugs requiring prior authorization In the Clinical Edit Supporting Tables section, revised tables to specify the diagnosis codes pertinent to steps 2, 3 and 4 of the logic diagram In the Clinical Edit Supporting Tables section, revised table to specify the procedure codes pertinent to step 5 of the logic diagram 10/26/2012 Added Modafinil 100mg and 200mg tablets to table of drugs requiring prior authorization 04/03/2015 Updated to include ICD-10s 10/05/2017 Annual review by staff Added dose check for modafinil to logic and diagram, pages 4-5 Added armodafinil to clinical edit Added criteria logic and diagram for armodafinil, pages Updated references, page 17 October 5, 2017 Copyright 2017 Health Information Designs, LLC 18
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